Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients With Limited Residual Disease After Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

July 12, 2002

Last Updated Date

June 23, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00041691 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients With Limited Residual Disease After Surgery

Official Title ^ICMJE

A Phase I, Single Dose Escalating Study to Investigate the Tolerability, Pharmacokinetics and Dosimetry of 90 Y-Humanized MN-14 IgG in Colorectal Cancer Patients With Limited Residual Disease After Primary or Salvage Surgery

Brief Summary

The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of residual colorectal cancer following recent surgery.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study

Condition ^ICMJE

Colorectal Neoplasms

Intervention ^ICMJE

Drug: hMN14 (labetuzumab)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Disease Characteristics:

Patients with documented histologic and cytologic diagnosis of colon or rectal malignancy
Patients with documented status post surgical resection of primary cancer or metastases
Limited residual disease (i.e., CEA serum levels < 15 ng/mL and negative baseline CT scans, or no lesion > 1 cm)

Prior/Concurrent Therapy:

Patients must have completed chemotherapeutic agents, biologic therapy, radiotherapy, other investigational therapy for cancer, or surgical procedures at least six weeks prior to study entry.
Patients must have recuperated from surgery and toxicities (as a result of previous therapy) sufficiently prior to study entry
Biologic Therapy: Patients who have received a murine, chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant reactivity with hMN-14 IgG (i.e., HAHA)
Radiotherapy: No prior external beam irradiation to a field that includes more than 30% of the red marrow. No prior radiation to maximal tolerable levels for any critical organs (e.g., 3000 cGy for the liver; 2000 cGy for the lungs and kidneys)

Patient Characteristics/Inclusion Criteria:

Performance Status: Patients with Karnofsky performance status > 70%
Hematopoietic: ANC >/= 1.5 x 10/L; Hemoglobin >/= 10 g/dL; Platelets >/= 100 x 10/L
Renal: Serum Creatinine </= 1.5 x ULN
Hepatic: Serum Bilirubin </= 1.5 ULN; AST and ALT </= 2.5 x ULN; Alk Phosphatase </= 2.5 x ULN
Cardiovascular: Patients with LVEF >/= 50% by required MUGA/2D-ECHO tests
Pulmonary: Patients with DF and FEV1 >/= 60% by required Pulmonary Function Tests
Central Nervous System: Patients with known metastatic disease to the CNS are excluded.
Other: Patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into study. Patients must understand and give written informed consent.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00041691

Responsible Party

Study ID Numbers ^ICMJE

IM-T-hMN14-06

Study Sponsor ^ICMJE

Immunomedics, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	Lauri Welles, MD	Immunomedics, Inc.
Study Director:	Terence Rugg, MD	Immunomedics, Inc.

Information Provided By

Immunomedics, Inc.

Verification Date

January 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP